PPA Advisory Alert

Has the FDA announced a recall of all drug products containing PPA?

Claim: Drug products containing PPA (phenylpropanolamine) were pulled from the market due to FDA concerns over a possible connection to strokes.

TRUE BUT OUTDATED

Examples:

[Collected via e-mail, January 2005]

All drugs containing PHENYLPROPANOLAMINE (PPA) are being recalled. You may want to try calling the 800 number listed on most drug boxes and inquire about a REFUND. Please read this CAREFULLY. Also, please pass this on to everyone you know.

STOP TAKING anything containing this ingredient. It has been linked to increased hemorrhagic stroke (bleeding in brain) among women ages 18-49 in the three days after starting use of medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine.

[Collected via e-mail, November 2000]

IMMEDIATE ACTION REQUIRED!! The FDA has announced a recall of all drug products containing PPA (phenylpropanolamine). The AAFES stock assortment contains 23 products containing this drug (see below) …. ALL MUST BE PULLED FROM SALE IMMEDIATELY and placed in controlled storage pending disposition instructions. In addition, customers presenting unused quantities of these items purchased from AAFES may be given full refunds. Locally printed signs will be placed as follows:

This recall action is mandatory and should be accomplished as soon as possible. Report compliance to respective Region retail offices via TAO. Contact CARTERRE with questions.

Origins: On 6 November 2000, the U.S. Food and Drug Administration (FDA) issued a public health advisory warning that phenylpropanolamine (PPA), an ingredient found in many over-the-counter cold medications and diet aids, may cause increase the risk of hemorrhagic stroke (bleeding into the brain) and thus should be avoided. Although the FDA did not issue a mandatory recall of PPA-containing products, they asked drug manufacturers to voluntarily stop selling products containing PPA and provide safer alternatives. As a result, most over-the-counter (OTC) products that formerly included PPA have long since been discontinued or reformulated without PPA.

The list of products cited in the e-mail quoted above (which originally circulated in 2000) is therefore several years out of date, as the FDA has noted:

We have received numerous requests for a list of products containing PPA. Since companies continue to reformulate their products, FDA is not maintaining a comprehensive, updated list of products that still contain PPA. FDA is aware of emails circulating widely that list many products allegedly containing PPA. These emails, however, generally contain dated and inaccurate information and should be ignored.

The FDA recommends that consumers read the labels of OTC drug products to determine if the product contains PPA. The Agency believes this to be the most accurate method for determining the PPA content of OTC products rather than providing an incomplete or out-of-date list of products that may have already been reformulated and no longer contain PPA.

The FDA set up a toll-free number for PPA questions at 888-INFO-FDA (a direct line, although it is not toll-free, is 301-827-4570) and published a Phenylpropanolamine (PPA) Information Page on their web site.

The FDA has advised that consumers go through their medicine cabinets, paying special attention to cold remedies and diet aids, and discard any medications that list phenylpropanolamine as one of their
ingredients.

According to the FDA, “Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA.” The FDA warning came as a result of a May 2000study conducted at Yale University School of Medicine, in which the Hemorrhagic Stroke Project found PPA to increase the risk of hemorrhagic stroke (which is ordinarily rare in young people). In October 2000, an FDA advisory committee confirmed the findings in the Yale study published by The New England Journal of Medicine, which suggested that PPA could raise the risk of stroke even among the 18 to 49 age group.